Nebivolol and the Endothelin (ET)-1 System | RxWiki

Nebivolol and the Endothelin (ET)-1 System

Overview[ - collapse ][ - ]

Purpose	The investigators hypothesize that nebivolol will reduce ET-1-mediated vasoconstrictor tone in adult humans with elevated blood pressure to a greater extent than either metoprolol or placebo.
Condition	Prehypertension Hypertension
Intervention	Drug: Nebivolol Drug: Metoprolol Drug: Placebo
Phase	Phase 4
Sponsor	University of Colorado, Boulder
Responsible Party	University of Colorado, Boulder
ClinicalTrials.gov Identifier	NCT01395329
First Received	June 9, 2011
Last Updated	May 8, 2012
Last verified	May 2012

Tracking Information[ + expand ][ + ]

First Received Date	June 9, 2011
Last Updated Date	May 8, 2012
Start Date	May 2011
Estimated Primary Completion Date	July 2013
Current Primary Outcome Measures	ET-1-mediated vasoconstrictor tone [Time Frame: Forearm blood flow will be measured at week 3 (before the 12 week drug or placebo intervention) and at week 15 (after the 12 week drug or placebo intervention).] [Designated as safety issue: No]Forearm blood flow is measured in response to Acetylcholine, Sodium Nitroprusside, BQ-123, BQ-788 and Acetylcholine combined with BQ-123 and BQ-788
Current Secondary Outcome Measures	Not Provided

Descriptive Information[ + expand ][ + ]

Brief Title	Nebivolol and the Endothelin (ET)-1 System
Official Title	Nebivolol and the Endothelin (ET)-1 System
Brief Summary	The investigators hypothesize that nebivolol will reduce ET-1-mediated vasoconstrictor tone in adult humans with elevated blood pressure to a greater extent than either metoprolol or placebo.
Detailed Description	1. The investigators hypothesize that nebivolol will reduce ET-1-mediated vasoconstrictor tone in adult humans with elevated blood pressure to a greater extent than either metoprolol or placebo. 2. The investigators further hypothesize that reducing ET-1 vasoconstrictor activity contributes to the improvement in endothelial vasodilator function associated with nebivolol.
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Condition	Prehypertension Hypertension
Intervention	Drug: Nebivolol 5 mg tablet to be taken by mouth once per day for 12 weeks Other Names: BystolicDrug: Metoprolol 100 mg tablet to be taken by mouth once per day for 12 weeks Other Names: Toprol-XLDrug: Placebo gelatin capsule to be taken by mouth once per day for 12 weeks
Study Arm (s)	Active Comparator: Nebivolol Active Comparator: Metoprolol Placebo Comparator: Placebo

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	48
Estimated Completion Date	July 2013
Estimated Primary Completion Date	July 2013
Eligibility Criteria	Inclusion Criteria: - Subjects will be men and women of all races and ethnic backgrounds aged 45-65 years. - Subjects will be prehypertensive/hypertensive defined as resting systolic blood pressure >130 mmHg and < 160 mm Hg and/or diastolic blood pressure >80 mmHg and < 100 mm Hg. - All of the women in the study will be postmenopausal (at least 1 year from last menstrual cycle) and not receiving hormone replacement therapy (HRT) currently or in the preceding 3-year period. - Lastly, candidates will be sedentary as determined from the Stanford Physical Activity Questionnaire (<35 kcal/wk) and will not have engaged in any program of regular physical activity for at least 1 year prior to the study. Exclusion Criteria: - Candidates who smoke (currently or in the past 7 years), report more than low-risk alcohol consumption as defined as no more than 14 standard drinks/wk and no more than 4 standard drinks/day for men and 7 standard drinks/wk and 3 standard drinks/day for women (a standard drink is defined as 12 ounces of beer, 5 ounces of wine, 1½ ounces of 80-proof distilled spirits) - Potential candidates who are taking cardiovascular-acting (i.e. statins, blood pressure medication an aspirin) medications will not be eligible. - Fasting plasma glucose >126 mg/dL. - Potential candidates with a resting heart rate of < 50 beats/minute will be excluded. - Use of hormone replacement therapy. - In hypertensive subjects, a seated systolic blood pressure greater than 160 mmHg or a seated diastolic blood pressure greater than 100 mmHg.
Gender	Both
Ages	45 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Contact: Jared J Greiner, M.S. 303-735-4955 jared.greiner@colorado.edu
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT01395329
Other Study ID Numbers	BYS-MD-57
Has Data Monitoring Committee	Yes
Information Provided By	University of Colorado, Boulder
Study Sponsor	University of Colorado, Boulder
Collaborators	Forest Laboratories
Investigators	Principal Investigator: Christopher A DeSouza, Ph.D. University of Colorado at Boulder
Verification Date	May 2012

Locations[ + expand ][ + ]